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The Compensation of Patients Injured in Clinical Trials

Creator

Barton, John M.

Macmillan, Maureen S.

Sawyer, Lindsay

Bibliographic Citation

Journal of Medical Ethics. 1995 Jun; 21(3): 166-169.

Abstract

The problem of 'no fault' compensation for patients who suffer adverse effects as a result of their participation in clinical trials is discussed in the light of the guidelines issued by the Association of the British Pharmaceutical Industry (ABPI) and our recent experiences in reviewing protocols submitted to the local ethics of surgical research sub-committee. We have found a variety of qualifications being applied by pharmaceutical firms which are not in the spirit of the guidelines, let alone the interests of the patient, and we suggest a means whereby the patient can be assured of fair treatment in the event of 'no fault' injury.

OBJECTIVE: To assess whether publicly funded adult cancer trials satisfy the uncertainty principle, which states that physicians should enroll a patient in a trial only if they are substantially uncertain which of the ...